Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients

NCT01042392 | Completed Phase 4 Results

• 2 other identifiers: CSPP100AFR012009-011296-80
• Study Type: interventional
• Target: 506
• Locations: 1 country
• Sites: 98

Brief Summary

This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.

Conditions

Essential Hypertension

Keywords

Moderate systolic hypertension - adults - aliskiren -ramipril

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

  The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP as covariable.

  Baseline to 8 weeks

Secondary Outcomes (8)

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

  Baseline to 8 weeks

• Percentage of Patients With Controlled Blood Pressure

  At 4 and 8 weeks

• Number of the Participants With More Than 55 mmHg Difference Between the Mean SBP Measured at the Morning Surge and the Mean Minimal SBP Measured During the Night

  After 8 weeks

• Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)

  Baseline to 4 weeks

• Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8

  At week 8

Study Arms (4)

Ramipril

ACTIVE COMPARATOR

In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in. In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4. In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4).

Drug: Ramipril; Drug: Matching placebo to Aliskiren

Aliskiren

EXPERIMENTAL

In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in. In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4. In period III (double-blind withdrawal ): At visit 4, part of the patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4).

Drug: Aliskiren; Drug: Matching placebo to Ramipril

Placebo to Ramipril

PLACEBO COMPARATOR

In period III (double-blind withdrawal ): At visit 4, part of patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).

Drug: Matching placebo to Ramipril

Placebo to Aliskiren

PLACEBO COMPARATOR

In period III (double-blind withdrawal ): At visit 4, part of the patients from Aliskiren arm received placebo to Aliskiren for 1 day. The study ended at visit 5 (48 hours later than visit 4).

Drug: Matching placebo to Aliskiren

Interventions

Aliskiren DRUG

150 mg Aliskiren as film-coated tablet

Aliskiren

Ramipril DRUG

Ramipril 5 mg was given in capsule form.

Ramipril

Matching placebo to Aliskiren DRUG

The tablet of matching placebo to aliskiren 150 mg for period I and III. In period II, matching placebo to Aliskiren was given to Ramipril active treatment arm.

Placebo to Aliskiren; Ramipril

Matching placebo to Ramipril DRUG

The placebo capsule to ramipril 5 mg for period I and III. In period II, matching placebo to Ramipril was given to Aliskiren active treatment arm.

Aliskiren; Placebo to Ramipril

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients \> 18 years
• Male or female patients. Female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods
• Patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant.
• BP thresholds at visit 1:
• For patients previously treated and uncontrolled: 140≤ office SBP\<180 mmHg
• For patients previously treated, controlled but intolerant: office SBP≥130 mmHg
• BP thresholds at visit 2 (for all patients):
• ≤office SBP\<180 mmHg AND
• ≤home SBP\<175 mmHg (3-day period of home blood pressure monitoring just before randomization)

You may not qualify if:

• Women of child-bearing potential not using any effective methods of contraception
• Severe hypertension (office BP ≥ 180/110 mmHg)
• Impossibility to stop abruptly previous antihypertensive treatments at visit 1
• Patients previously untreated or patients treated with two or three antihypertensive medications
• History or evidence of a secondary form of hypertension
• History of hypersensitivity to ACEi or renin inhibitors
• History of heart failure, stroke or coronary heart disease
• Serum potassium ≥ 5.2 mmol/l

Sponsors & Collaborators

• Novartis: lead

Study Sites (98)

Novartis Investigative Site

Aire Sur Adour, France

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Amboise, France

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Angers, France

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Anzin, France

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Bachant, France

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Bandol, France

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Bersée, France

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Bécon-les-Granits, France

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Bordeaux, France

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Bouliac, France

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Bourges, France

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Briollay, France

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Bruges, France

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Caen, France

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Carbonne, France

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Chatillon Sur Colmon, France

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Château-Gontier, France

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Châtellerault, France

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Cherbourg, France

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Cournonterral, France

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Croix, France

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Cugnaux, France

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Écouflant, France

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Équeurdreville-Hainneville, France

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Falaise, France

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Fondettes, France

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Guérigny, France

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Hautmont, France

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L'Aigle, France

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La Farlède, France

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La Riche, France

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La Rochelle, France

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Labarthe-sur-Lèze, France

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Lambersart, France

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Laval, France

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Le Bouscat, France

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Le Cailar, France

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Le Fousseret, France

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Le Pradet, France

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Les Maguelone, France

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Luynes, France

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Marcheprime, France

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Marseille, France

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Marsilly, France

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Novartis Investigator Site

Marsilly, France

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Mayenne, France

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Médis, France

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Mont-de-Marsan, France

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Montpellier, France

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Montrevault, France

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Monts-sur-Guesnes, France

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Mortagne-sur-Sèvre, France

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Mourmelon-le-Petit, France

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Nantes, France

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Nevers, France

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Nieul-sur-Mer, France

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Orchies, France

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Paris, France

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Périgny, France

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Potigny, France

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Reims, France

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Roquevaire, France

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Rouen, France

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Saint-Avertin, France

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Saint-Benoît, France

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Saint-Cyr-sur-Loire, France

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Saint-Cyr-sur-Mer, France

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Saint-Georges-dOrques, France

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Saint-Germain-de-Marencennes, France

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Saint-Loubès, France

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Saint-Martin-d'Oney, France

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Saint-Orens-de-Gameville, France

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Saint-Orens-de-Gameville, France

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Saint-Rogatien, France

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Saint-Seurin-de-Cursac, France

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Saint-Xandre, France

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Sainte-Marie-de-Ré, France

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Sanary-sur-Mer, France

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Savonnières, France

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Scorbé-Clairvaux, France

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Scorbé-Clairvaux, France

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Segré, France

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Seysses, France

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Sotteville-lès-Rouen, France

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Strasbourg, France

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Thun-Saint-Amand, France

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Tiercé, France

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Toulon, France

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Toulon, France

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Toulouse, France

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Tours, France

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Trélazé, France

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Vendôme, France

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Vereneque, France

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Verzy, France

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Vierzon, France

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Vieux-Condé, France

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Witry-lès-Reims, France

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Related Publications (1)

• Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.

  PMID: 33089502 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

aliskiren; Ramipril

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2010
• First Posted: January 5, 2010
• Study Start: November 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: April 3, 2012
• Results First Posted: April 3, 2012

Record last verified: 2012-03

Locations

FR (98)